RecruitingNCT01420562

Pharmacokinetics of Posaconazole in Allogeneic Transplant Patients With Mucositis


Sponsor

Universitaire Ziekenhuizen KU Leuven

Enrollment

55 participants

Start Date

Sep 1, 2011

Study Type

OBSERVATIONAL

Conditions

Summary

The goal of this study is to calculate pharmacokinetic parameters and to evaluate the trough levels of posaconazole reached in patients with different stages of mucositis, due to chemotherapy and total body irradiation.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study looks at how the antifungal drug posaconazole is absorbed by the body in patients who have recently had an allogeneic (donor) stem cell transplant and are experiencing mucositis — painful inflammation and ulcers in the mouth and digestive tract. Mucositis may affect how well the drug is absorbed, and this study aims to find the right dosing approach. You may be eligible if: - You are 18 to 75 years of age - You are receiving an allogeneic stem cell transplant - You are being prescribed posaconazole (oral suspension or tablet) to prevent fungal infections You may NOT be eligible if: - You have gastroparesis (a condition where your stomach empties too slowly) - You have vomiting or diarrhea within 2 hours of taking posaconazole - You are taking enzyme-inducing medications such as carbamazepine, phenytoin, phenobarbital, rifampicin, or similar drugs - You are under 18 years of age Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREblood sampling

During posaconazole treatment, blood sampling will occur on day 0 (=day of transplantation), day 7 and 14 to correlate posaconazole exposure to severity of mucositis.


Locations(1)

University Hospitals Leuven

Leuven, Vlaams-Brabant, Belgium

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NCT01420562


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